Ibuprofen
IBUPROFEN Tablets, USP
57a1bf99-5aaf-432d-86ba-5f0e7cfab1a0
HUMAN PRESCRIPTION DRUG LABEL
Apr 22, 2025
REMEDYREPACK INC.
DUNS: 829572556
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: Ibuprofen
GENERIC: Ibuprofen
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-0176-0
NDC: 70518-0176-1
NDC: 70518-0176-2
COLOR: white
SHAPE: OVAL
SCORE: No score
SIZE: 19 mm
IMPRINT: I;10
PACKAGING: 30 in 1 BOTTLE, PLASTIC
PACKAGING: 90 in 1 BOTTLE, PLASTIC
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- IBUPROFEN 800mg in 1
INACTIVE INGREDIENT(S):
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- HYPROMELLOSE 2910 (5 MPA.S)
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL 400
- STARCH, CORN
- POVIDONE K90
- SODIUM LAURYL SULFATE
- TITANIUM DIOXIDE
DESCRIPTION SECTION
DESCRIPTION
Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-(
p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting
point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily
soluble in organic solvents such as ethanol and acetone. The structural
formula is represented below:
Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.